Packages for medical devices, including surgical needles and sutures are well known in the art. Surgical sutures are typically manufactured with surgical needles mounted to one or both ends of the suture. The surgical needle and suture combinations are typically packaged in a variety of conventional packages. One type of conventional package typically used is a folder package made from a stiff, medical grade paper. A folder package will typically have a plurality of foldable panels and cut-out tabs and tab pockets. In addition, a needle park is typically mounted to one of the panels for receiving and holding one or more surgical needles. In order to package a surgical suture and surgical needle combination in a conventional folder package, the needle is first typically mounted in a needle park, then the suture is wound onto one or more of the panels and the folder package is folded and locked to securely maintain the needle and suture in the panel. Folder packages for surgical needles and sutures are illustrated and disclosed in the following patents which are incorporated by reference: U.S. Pat. Nos. 4,126,221, 4,120,395 and 5,555,976.
Another type of conventionally used suture package is a molded plastic tray package having a central floor surrounded by an outer winding channel for receiving and retaining a suture, e.g., an oval channel. This type of package typically has a centrally located needle park molded into the package. A surgical needle mounted to a surgical suture is typically packaged in the winding channel by initially mounting the surgical needle in the needle park and then winding the suture in the channel. Winding is typically accomplished by mounting the tray package in a fixture and rotating the fixture and mounted package. A cover may be mounted to the top of the winding channel package, or the package may have molded retainer elements, in order to maintain the suture in the channel. Suture tray packages having winding channels are illustrated in the following which are incorporated by reference: U.S. Pat. Nos. 4,967,902, 5,213,210 and 5,230,424.
Surgical needles and sutures are typically sold by the manufacturer as sterile products. In order to sterilize a packaged surgical needle and suture, it is first necessary to place the primary package into an outer package. The outer package is then sealed and functions as a biobarrier to pathogens, in particular, bacteria. The outer packages are often referred to in this art as envelopes or pouches, and the biobarriers are often referred to as microbial barriers. There are various types of conventional materials which are useful to construct these outer packages, including foil laminates, polymer films, TYVEK.RTM. spun polymer films and the like. There are a variety of conventional processes which can be used to sterilize packaged surgical needles and sutures including autoclaving, radiation sterilization and ethylene oxide sterilization. In general, the packaging material utilized for the outer package is selected on the basis of the sterilization technique utilized and the material of construction of the medical device.
Ethylene oxide sterilization is a sterilization process of choice for many medical devices. In a conventional ethylene oxide sterilization process for medical devices, the packaged devices contained in sealed outer envelopes or pouches are initially subjected to a vacuum, next to a predetermined level of water vapor, and then to a conventional ethylene oxide gas sterilant for a predetermined time at a predetermined temperature. The cycle is calculated to effectively kill off any pathogenic bioburden with an acceptable safety factor. At the end of the sterilization phase of the cycle, the packages are exposed to a vacuum sufficient to effectively remove the sterilant gas from the interiors of the envelopes or pouches along with any sterilant gas residues from the packages and the medical devices, thus completing the sterilization cycle. Since the moisture and the sterilant gas must have access to the interior of the outer package and the inner primary package containing the medical device, it is typically necessary to have some sort of gas permeable material present in the outer package to allow air, water vapor and sterilant gas to enter and exit the outer package. A conventional outer package (envelope or pouch) for use with ethylene oxide sterilization processes typically has a top clear polymer film which is gas impervious. The clear film is sealed or bonded about its periphery to a bottom microbial barrier member constructed of paper or a film of TYVEK.RTM. spun polymer (or an equivalent) which is gas permeable. Moisture and sterilant gas can move across the microbial barrier member into and out of the outer package.
Certain types of medical devices, such as surgical sutures, are designed to absorb when implanted into the human body. These absorbable sutures are made from conventional, widely known absorbable polymers which are moisture sensitive. In order to maintain the strength and integrity of the absorbable medical devices and prevent degradation while being shipped, or stored prior to use, it is essential that the outer package be moisture impervious, i.e., hermetically sealed. Accordingly, the conventional gas permeable microbial barrier outer pouch packages cannot be used for absorbable medical devices. It is necessary to use an outer package which is impervious to water vapor and gases, such as a conventional polymer/metal foil laminate pouches typically referred to in this art as a "foil pouch".
It is desirable to sterilize packaged synthetic, absorbable medical devices, such as surgical sutures, using ethylene oxide sterilization processes. Radiation or high temperatures may adversely affect the absorbable polymers. However, sealed foil pouches are also impervious to sterilant gas. In order to compensate for this and utilize foil packages in ethylene oxide gas sterilization processes, processes have been developed using foil pouches having gas permeable or pervious vents (e.g., TYVEK.RTM. polymer). The gas permeable vents are mounted to an open end of the foil package and allow the passage of air, water vapor and sterilant gas into the interior of the package. After sterilization, the foil package is sealed adjacent to the vent, and the vent is cut away or otherwise removed, thereby producing a gas impervious hermetically sealed package. Yet another type of foil package having a vent is a pouch-type package having a vent mounted adjacent to an end of the package, wherein the vent is sealed to one side of the package creating a vented section. After sterilization, the package is sealed adjacent to the vent, and the package is cut away for the vented section. This vented package will be described in more detail hereinbelow.
Alternatively, processes have been developed for sterilizing foil packages without the use of gas permeable vents. This is done by sealing the foil package substantially about its periphery (e.g., on three sides) but leaving a portion of the package open, typically the top end, as a pathway for the sterilant gas, etc. This type of process is known as an "open vent" process. In an open vent process, after the sterilization cycle has been completed the opening in each package is sealed under aseptic conditions, providing for a hermetically sealed foil package having a sterile interior. An example of such a process is disclosed in U.S. Pat. No. 3,815,315 which is incorporated by reference. Another example of an open vent sterilization process useful for an open vent package is contained in U.S. Pat. No. 5,464,580 which is incorporated by reference.
It is known to form foil packages in a multiple pack format to contain multiple suture packages. These outer packages have multiple cavities, for example, eight cavities. A surgical suture package is placed in each cavity, and each cavity is sealed about its periphery on three sides, leaving an opening(i.e., an open vent) in communication with each cavity. After ethylene oxide sterilization, the openings are subsequently sealed aseptically, and the packages are separated into unitary packages. Such sterilization processes, foil packages and methods of forming the packages are disclosed in U.S. Pat. Nos. 5,464,580 and 5,623,810 which are incorporated by reference. Although such foil packages having multiple cavities are conventionally utilized, there are some disadvantages associated with their use. For example, in order to sterilize the multiple cavity packages, the pathway to each cavity must be kept open. Then, after sterilization, the packages must be maintained in aseptic environments prior to and during sealing. It is known that it is difficult and costly to maintain aseptic conditions in large volumetric facilities required for aseptic package storage and sealing. In addition, moisture must be precisely controlled in the aseptic environments to prevent degradation of bioabsorbable medical devices. It is also known that different levels of sterilization may be attainable with packages having microbial barriers versus packages having open vents.
Accordingly, there is a need in this art for a novel foil package, especially a multiple cavity foil package, for absorbable sutures and other medical devices which does not require aseptic sealing after sterilization and which can be immediately placed in a nonsterile environment prior to further processing for conversion to a hermetically sealed, sterile package. There is a further need for processes for sterilizing surgical sutures and needles and other medical devices in foil packages or pouches, in particular multiple cavity foil packages, without the need for aseptic processing.